FDA.reportPublic FDA data

Pure Comfort Breath Exerciser

Primary DI
00860006377830
Brand
Pure Comfort Breath Exerciser
Company
HOME AIDE DIAGNOSTICS, INC.
Model
7830
Device description
Pure Comfort Breath Exerciser
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRHSystem, Breath Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRHSystem, Breath MeasurementClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006377837PackageGS150In Commercial Distribution
00860006377830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000637783710860006377837
00860006377830008600063778308600063778300860006377830

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
8009150116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015635518Ultra-Care Disposable Safety Lancets 30GUCSLAN2026-05-05
00850071765069Easy Comfort Safety Lancets 30G 100cntECSLAN2026-05-01
00891237001195Easy Step Blood Glucose Test Strips 50ctT5D2-0011952016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ct20002004914232016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ct881814852016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct881816452016-05-03
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
00850027494661"Easy Comfort Syringes 31G 1/2"" 0.3CC"46612024-10-08
00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
00850027494340True Comfort Knee Compression Wrap43402024-10-08
00850027494357Pure Comfort Leg Massager43572024-10-08
00850027494388Ultra Comfort Body Massager43882024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQUINTRON INSTRUMENT COMPANY, INC.NRH2025-03-19
10860006377837Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
00850010197982SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USPQUINTRON INSTRUMENT COMPANY, INC.NRH2024-03-18
05060246860399GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-15
05060246860108GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
05060246860153GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
00850010197937LOANER ALVEOVAC EXTRACTORQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197944EXTRACTOR REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197906BT GC LOANER SCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197913BREATHTRACKER SERIES REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197234DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197272VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197371STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197210FILTER, FOAM PLUG, 10 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197227Patient Sample Drying TubeQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197869DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197265SX2 Plus Maintenance KitQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197876VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197302Tank Support, Safety, Table-Top PlasticQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197357Drying Tube End, Sample Inlet, FemaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197364Drying Tube End, Sample Inlet, MaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197883STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197395SivRite-4 Tubing AssemblyQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197418Screwdriver, Valve Removal ToolQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197456Extraction System Output TubingQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197500AlveoVac Exraction System-USA 24VDCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197258BreathPrep DesiccantQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197449BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197463BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20